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Manual on Good Practices in Public Health-Sensitive Policy Measures and Patent Laws
By Third World Network
Published by: Third World Network
Year Published: 2003
No of Pages: 111
Price: First World - $12.00 (postage cost by air mail, add $3.50); Third World - $9.00 (postage cost by air mail, add $2.50)

The international intellectual property standards enshrined in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have priced many essential drugs out of reach of poor patients by awarding patent holders monopoly rights over these products. Nevertheless, nestled within the folds of the Agreement itself are provisions which do enable governments to override exclusive patent rights in order to secure access to affordable medicines.

This Manual examines the TRIPS-consistent policy measures to which states may have recourse for the purpose of producing, importing and exporting lower-priced versions of the patented drugs they need. Detailed suggestions are advanced, by way of model legal provisions, as to how governments may give effect to each of these measures - compulsory licensing, parallel importation, government use and exceptions to patent rights - in their national patent laws. In addition, the Manual discusses the domestic administrative and institutional framework required for the equitable and effective implementation of these provisions.

The outcome of a series of expert workshops and consultations organized by the Third World Network, this Manual will serve as a practical guide for policymakers and citizen groups in efforts to formulate intellectual property disciplines which meet not only the legal obligations of the TRIPS Agreement but also the moral imperative of safeguarding public health.

Contents

Preface
Acknowledgements     
Introduction         

PART I  TRIPS-CONSISTENT OPTIONS FOR AFFORDABLE MEDICINES: MEASURES FOR IMPORT, DOMESTIC PRODUCTION

AND EXPORT          

Chapter 1  Import  

A.  Importation under Government Use  
B.   Importation through Compulsory Licence     
C.  Compulsory Licence to Import in Cases of Emergency or “Other Circumstances of Extreme Urgency”     
D.  Importation through Parallel Import  

Chapter 2  Local Production

A.  Manufacture of Non-Patented Drug       
B.   Manufacture through Government Use         
C.  Compulsory Licence for Local Manufacture          
D.  Compulsory Licence to Manufacture in Situation of Emergency or Extreme Urgency       

Chapter 3  Export    

A.  Export of Products Produced under Government Use and Compulsory Licences B.   Export under Article 30 of TRIPS    

PART II  MODEL LEGAL PROVISIONS FOR PUBLIC-HEALTH-SENSITIVE PATENT LAWS         

Chapter 4  Parallel Import       

Model Provision            
Explanatory Notes         

A.  Effect of Model Provision          
B.   Objective and Rationale   
C
.  TRIPS-Compliance       
D.  Examples of State Practice         

Chapter 5  Public, Non-Commercial Use (Government Use)      

Model Provision            
Explanatory Notes         

A.  Effect of Model Provision      
B.   Objective and Rationale             
C.  TRIPS-Compliance       
D.  Examples of State Practice         

Chapter 6  Exceptions to Patent Rights        

Model Provision            
Explanatory Notes         

A.  Effect of Model Provision   
B.   Objective and Rationale         
C.  TRIPS-Compliance       
D.  Examples of State Practice       

Chapter 7  Compulsory Licence    

Model Provision          
Explanatory Notes         

A.  Effect of Model Provision          
B.   Objective and Rationale             
C.  TRIPS-Compliance       
D.  Examples of State Practice         

PART III  PROPOSALS FOR AN APPROPRIATE INSTITUTIONAL AND ADMINISTRATIVE FRAMEWORK FOR PUBLIC  HEALTH-SENSITIVE PATENT LAWS         

Chapter 8  The Competent Authority     

A.  Individual Merits      
B.   Prior Negotiations    
C.  Appeals Procedure and Remedies    
D.  Anti-Competitive Practices  

Chapter 9  Adequate Remuneration or Compensation        

A.  Compensation Committee  
B.   Compensation Guidelines     

Bibliography  

Annex 1     Relevant Provisions of the TRIPS Agreement    
Annex 2  Doha Declaration on the TRIPS Agreement and  Public Health   

 


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